physiology-guided vs angiography-guided non-culprit lesion complete revascularization for acute mi & multivessel disease

Conditions: Acute Myocardial Infarction; Coronary Artery Disease

Summary: complete-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute st-segment elevation myocardial infarction (stemi) or non-st-segment elevation myocardial infarction (nstemi) and multivessel coronary artery disease (cad) who have undergone successful culprit lesion percutaneous coronary intervention (pci). complete-2 oct is a large scale, prospective, multi-centre, observational, imaging study of patients with stemi or nstemi and multivessel cad in a subset of eligible complete-2 patients.

complete-2 study objectives 1. to determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular (cv) death, new myocardial infarction (mi) or ischemia-driven revascularization (idr). 2. to determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

Eligibility criteria:
inclusion criteria: 1. patients presenting with stemi or type 1 nstemi and within 72 hours of successful culprit-lesion pci 2. residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria: 1. amenable to successful treatment with pci 2. at least 50% diameter stenosis by visual estimation 3. at least 2.5 mm in diameter 3. planned complete revascularization strategy for qualifying mi exclusion criteria: 1. planned or prior coronary artery bypass graft (cabg) surgery 2. inability to clearly identify a culprit lesion for stemi or nstemi based on angiographic appearance and/or ecg changes and/or regional wall motion abnormalities 3. prior pci of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization 4. planned medical treatment of all qualifying non-culprit lesions (i.e., no pci) 5. presence of severe non-culprit-lesion stenosis with reduced epicardial flow (timi flow ≤ 2) or \>90% visual diameter stenosis 6. presence of a chronic total occlusion (cto) if it is the only qualifying non-culprit lesion (patients with a cto plus additional qualifying non-culprit lesions are eligible) 7. the only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion 8. baseline stemi or nstemi was due to a suspected non-atherothrombotic mechanism such as type 2 mi (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism 9. non-cardiovascular co-morbidity with expected life expectancy \<2 years 10. any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Keywords: nstemi stemi multi-vessel disease optical coherence tomography ffr rfr percutaneous coronary intervention